MAUDE Adverse Event Report: DELTA MED SPA DELTAVEN FAST FLASH; INTRAVASCULAR IV CATHETER

Model Number	3811473
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
With reference to report fda # (b)(4) we have collected from our warehouse n.3 sterile devices of the same lot of deltaven y dnl g24x19mm batch 11t15311 involved in the incident.I - tests performed on n.3 deltaven y dnl g24x19mm batch 11t15311 code 3811473 to verify the displacement and malfunction of the device.1) leakage test performed at a pressure generated by a column of fluid 400+/- 10mm high filled in with simulated blood to simulate the use of the catheter and verify the leakage at low pressure of all its components from the actual intravenous catheter up to the final vent fitting, including the assembled nl valve.During the extraction of the needle from the catheter, the correct activation of the safety device designed to protect the operator from accidental needle sticks injuries has been checked.The test report is provided in annex a.2) high pressure leak test performed at 23 bar (330 psi) to verify whether there are micro cracks in the device that cause leaks that are easily detectable at high pressure.Test report is provided in annex b.Basing on the checks performed and above documented on the devices of the same batch involved in the incident, no manufacturing defects were identified that could have caused leaks from the fittings and the device as a whole.With these tests, any serial defect is certainly excluded.Since the devices involved in the incident is not available, we are not able to establish exactly the cause of the leak even with multiple replacements of the nl valve.
Event or Problem Description
The safety hub has a crack in it and was leaking.I switched out 3 different (including the one that came with the intravenous line (iv) set) microclave connectors., but the leaking continued.Since i was going to be injecting a radioactive dose, i could not use this iv because i did not want radioactivity to leak our the iv.So i had to start another iv on the patient.

• Brand Name: DELTAVEN FAST FLASH
• Common Device Name: INTRAVASCULAR IV CATHETER
• Manufacturer (Section D): DELTA MED SPA; via guido rossa 20; viadana, mantova 46019 ; IT 46019
• Manufacturer (Section G): DELTA MED SPA; via e. segrè 6; sorbolo a levante, reggio emilia 42041 ; IT 42041
• Manufacturer Contact: priscilla tagliaferri ; via guido rossa 20; viadana, mantova 46019 ; IT 46019
• MDR Report Key: 20450744
• Report Number: 3006846316-2024-00002
• Device Sequence Number: 9232128
• Product Code: FOZ
• UDI-Device Identifier: 38032248381149
• UDI-Public: 38032248381149
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3811473
• Device Catalogue Number: 3811473
• Device Lot Number: 11T15311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown